FDA Adverse Event
Injury
Summary report: N
TVL LEAD, RIGHT VENTRICULAR
MDR report key: 1223130
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03739
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A DEVICE REPLACEMENT PROCE- DURE, AN INDUCTION TEST WAS PERFORMED. THE DEVICE REPORTED HIGH VOLTAGE LEAD IMPEDANCE OF 0 OHMS. WHEN AN HVLIC WAS REQUESTED, THE DEVICE REPORTED A HIGH IMPEDANCE VALUE. WHEN THE POCKET WAS OPENED, THE PHYSICIAN OBSERVED A LEAD FRACTURE. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TVL LEAD, RIGHT VENTRICULAR | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | RV02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |